FDA 510(k)

DUAL SHOT - CONTRAST DELIVERY SYSTEM

K-Number: K052633 · 2005-10-17

Decision Date2005-10-17

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DUAL SHOT - CONTRAST DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nemoto Kyorindo Co., Ltd.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052633. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL SHOT - CONTRAST DELIVERY SYSTEM?

DUAL SHOT - CONTRAST DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K052633.

When did DUAL SHOT - CONTRAST DELIVERY SYSTEM receive FDA 510(k) clearance?

DUAL SHOT - CONTRAST DELIVERY SYSTEM received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052633.

Who is the listed applicant for DUAL SHOT - CONTRAST DELIVERY SYSTEM?

The FDA 510(k) record lists Nemoto Kyorindo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL SHOT - CONTRAST DELIVERY SYSTEM?

The FDA product code for DUAL SHOT - CONTRAST DELIVERY SYSTEM is DXT.

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Other records listing Nemoto Kyorindo Co., Ltd. as applicant

K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)K173450PRESS DUO elite, PRESS DUO elite AG K092896REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS K091734SONIC SHOT GX K071691DUAL SHOT ALPHA K062168CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

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Related Devices (Code: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.